Diltiazem Hydrochloride

Product NDC: 48433-032
Requested package NDC: 48433-032-20
11-digit product format: 484330032
Labeler code: 48433
Product ID: 48433-032_49eef6c8-e1fc-86af-e063-6294a90a0309
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diltiazem hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Safecor Health LLC
Application: ANDA074910
Marketing category: ANDA
Marketing start: 2026-02-02
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 120 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074910-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02
A074910-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02
A074910-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A074910-001	AB1
A074910-002	AB1
A074910-003	AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 109 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074910-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074910-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074910-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074910-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074910-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074910-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074910-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074910-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074910-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074910-001	AB1	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diltiazem Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DILTIAZEM HYDROCHLORIDE	120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
OLH94387TE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
830865	Internal RxNorm lookup
830869	Internal RxNorm lookup
830872	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fc02db0f-5311-4b61-896e-bfe340832735	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
61ebbccf-eedf-453b-940e-dba67b7a5fef	Product name	4	20260107
a8d6eaa3-afcc-47e5-be12-0c9251fc8740	Product name	1	20251124
f6700316-a6ba-5e59-3413-8ede05ae58b9	Product name	7	20250625
8615f7a1-1e8f-8281-8601-d7a637926d1f	Product name	4	20250522
3a9daa2f-bcd1-13de-a1b4-6172caa7f308	Product name	2	20240419
f7129636-cba8-86c2-8bfb-9e2e2a9c7628	Product name	2	20240314
378290be-e30f-0e68-1201-165e93c337e8	Product name	3	20231212
c733b56e-b0b5-4495-9857-0256a8242279	Product name	1	20220520
f4df4721-60d9-7fd2-a665-5c3c9f55af81	Product name	2	20171003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48433-032-01	Diltiazem Hydrochloride	1 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	1		2
48433-032-20	Diltiazem Hydrochloride	100 in 1 CARTON	CAPSULE, EXTENDED RELEASE	100		2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Safecor Health LLC	fc02db0f-5311-4b61-896e-bfe340832735	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074910 application number: ANDA074910 ndc (package): 48433-032-20 ndc (product): 48433-032 ndc11 (package): 48433003220
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	ec7e93b8-666c-4d2f-8d08-07931e09f748	2025-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074910 application number: ANDA074910
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Mylan Institutional Inc.	9942f1a2-f66d-4d9e-9794-49bee8abf5ab	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074910 application number: ANDA074910
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Coupler LLC	2ced821f-19a6-4c7e-e063-6394a90adb80	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074910 application number: ANDA074910

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OLH94387TE	DILTIAZEM HYDROCHLORIDE	33286-22-5	DILTIAZEM HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
830872	dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral Capsule	PSN	fc02db0f-5311-4b61-896e-bfe340832735	2
830865	dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral Capsule	PSN	fc02db0f-5311-4b61-896e-bfe340832735	2
830869	dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral Capsule	PSN	fc02db0f-5311-4b61-896e-bfe340832735	2
830872	12 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule	SCD	fc02db0f-5311-4b61-896e-bfe340832735	2
830865	12 HR diltiazem hydrochloride 60 MG Extended Release Oral Capsule	SCD	fc02db0f-5311-4b61-896e-bfe340832735	2
830869	12 HR diltiazem hydrochloride 90 MG Extended Release Oral Capsule	SCD	fc02db0f-5311-4b61-896e-bfe340832735	2
830872	diltiazem hydrochloride 120 MG 12 HR Extended Release Oral Capsule	SY	fc02db0f-5311-4b61-896e-bfe340832735	2
830865	diltiazem hydrochloride 60 MG 12 HR Extended Release Oral Capsule	SY	fc02db0f-5311-4b61-896e-bfe340832735	2
830869	diltiazem hydrochloride 90 MG 12 HR Extended Release Oral Capsule	SY	fc02db0f-5311-4b61-896e-bfe340832735	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
48433-032-20	48433003220	100 BLISTER PACK in 1 CARTON (48433-032-20) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (48433-032-01)	100 blister pack	2026-02-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride - Safecor Health LLC	Safecor Health LLC	2026-02-03	HUMAN PRESCRIPTION DRUG LABEL	2